Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin
2 other identifiers
interventional
40
1 country
3
Brief Summary
Considering that, Diacerein is on the market for 16 years being used continuously in elderly patients with osteoarthritis without experience significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes treated with this medicine. The aim of this study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2013
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedJuly 5, 2017
July 1, 2017
2.6 years
June 27, 2017
July 3, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Fasting Glucose
4 weeks
HbA1c - glycated haemoglobin
12 weeks
Cholesterol
12 weeks
Study Arms (2)
Diacerein
ACTIVE COMPARATORDiacerein 50 mg immediate release capsule, once daily for the starting 28 days and Diacerein 50 mg immediate release capsule twice a day for the remainder of the study.
Placebo
PLACEBO COMPARATORPlacebo capsules once a day for the starting 28 days and two times daily for the remainder of the study.
Interventions
Eligibility Criteria
You may qualify if:
- Diabetes mellitus type 2 between 6 months to 10 years of disease
- Body mass index between 25 and 35 kg/m2
- Fasting glucose between 120 and 250 mg / dL
- Glycated Hb A1c greater than 7,5 % and taking metformin (dose above 1700 mg / day) with or without other secretagogue
- Male or female (not pregnant), who present clinical symptoms of type 2 diabetes between 6 months to 10 years of disease, according to the diagnostic criteria.
You may not qualify if:
- Patients with DM1, DM2 using insulin and other types of diabetes
- T2DM with chronic complications that already have clinical consequences
- Creatinine serum greater than 1.4 (female) and 1.5 mg/dl (male)
- History of heart disease and severe concomitant diseases such as liver, coronary artery, renal, with severe psychiatric or neurological disorders
- Patients with a history of abuse of alcohol and/or illegal drugs or psychotropic medicines in the past six months
- Hypersensitivity to any component of the of study drug and placebo formulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANS Pharmalead
- University of Campinas, Brazilcollaborator
- Conselho Nacional de Desenvolvimento Científico e Tecnológicocollaborator
Study Sites (3)
Centro de Estudos em Diabetes e Hipertensão
Fortaleza, Ceará, Brazil
Universidade Estadual de Feira de Santana
Feira de Santana, Estado de Bahia, Brazil
Universidade Estadual de Campinas
Campinas, São Paulo, Brazil
Related Publications (4)
Ramos-Zavala MG, Gonzalez-Ortiz M, Martinez-Abundis E, Robles-Cervantes JA, Gonzalez-Lopez R, Santiago-Hernandez NJ. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care. 2011 Jul;34(7):1591-4. doi: 10.2337/dc11-0357. Epub 2011 May 24.
PMID: 21610123BACKGROUNDVelloso LA, Folli F, Perego L, Saad MJ. The multi-faceted cross-talk between the insulin and angiotensin II signaling systems. Diabetes Metab Res Rev. 2006 Mar-Apr;22(2):98-107. doi: 10.1002/dmrr.611.
PMID: 16389635BACKGROUNDTobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Prada PO, Saad MJ. Comment on: Ramos-Zavala et al. Effect of diacerein on insulin secretion and metabolic control in drug-naive patients with type 2 diabetes: a randomized clinical trial. Diabetes Care 2011;34:1591-1594. Diabetes Care. 2012 Feb;35(2):e13; author reply e14. doi: 10.2337/dc11-1856. No abstract available.
PMID: 22275450BACKGROUNDTobar N, Oliveira AG, Guadagnini D, Bagarolli RA, Rocha GZ, Araujo TG, Santos-Silva JC, Zollner RL, Boechat LH, Carvalheira JB, Prada PO, Saad MJ. Diacerhein improves glucose tolerance and insulin sensitivity in mice on a high-fat diet. Endocrinology. 2011 Nov;152(11):4080-93. doi: 10.1210/en.2011-0249. Epub 2011 Sep 6.
PMID: 21896669BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2017
First Posted
July 5, 2017
Study Start
January 1, 2013
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
July 5, 2017
Record last verified: 2017-07